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FDA PMA

Caries detection product with drug or biologic

PMA Number: P170029 · 2025-03-03

ApplicantCalcivis Limited
Decision Date2025-03-03
PMA NumberP170029
Product CodeQJX
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeDE

Device Summary

Caries detection product with drug or biologic is the device name listed in this FDA PMA record. The listed applicant is Calcivis Limited. It received FDA Premarket Approval (PMA) on 2025-03-03 under PMA number P170029. The device is classified under FDA product code QJX. It was reviewed by the DE advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Caries detection product with drug or biologic?

Caries detection product with drug or biologic is a medical device that received FDA Premarket Approval (PMA) on 2025-03-03. The listed applicant is Calcivis Limited. The PMA number is P170029.

When did Caries detection product with drug or biologic receive FDA PMA approval?

Caries detection product with drug or biologic received FDA PMA approval on 2025-03-03, under PMA number P170029.

Who is the listed applicant for Caries detection product with drug or biologic?

The FDA PMA record lists Calcivis Limited as the applicant. This does not by itself establish the device manufacturer.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Caries detection product with drug or biologic?

The FDA product code for Caries detection product with drug or biologic is QJX.

What FDA device class is Caries detection product with drug or biologic?

Caries detection product with drug or biologic is classified as Class III by the FDA.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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